Umbilical or Peripheral Catheter Insertion for Preterm Infants on Admission to the NICU (UP)

University College Dublin

Status: Unknown

Conditions: Preterm Birth Complication; Hypothermia, Newborn; Neonatal Hypothermia

Treatments: Procedure: Vascular access on admission

Study type: Interventional

Funder types: Other

Identifiers

NCT04761484

APOLLO_UP

Details and patient eligibility

About

Preterm infants are at risk of hypothermia following delivery and in the first few hours of life. Hypothermia in extremely low birth weight infants' is an independent risk factor for death. These infants' are at additional risk of hypothermia when they undergo procedures such as central catheter insertion following admission.

The investigators think that in extremely preterm infants, placing a peripheral intravenous cannula on admission to the NICU, instead of umbilical catheters (UVC and/or UAC), will increase the proportion of infants with a rectal temperature in the normal range at 2 hours of life.

Full description

Hypothermia is an independent risk factor for death in preterm newborns.(1) Despite measures to improve temperature in preterm newborns in the delivery room (DR), hypothermia on admission to the neonatal intensive care unit (NICU) at NMH is common. In a cohort of infants < 32 weeks' gestation born at NMH in 2019, 54% of infants had a rectal temperature < 36.5 oC on admission to the NICU.(2)

Many preterm infants have procedures performed soon after admission to the NICU; in 2019, 98% of infants born before 29 weeks' gestation at NMH had an umbilical venous catheter inserted. This may/often involve(s) prolonged periods of handling and potential exposure to cold.

The investigators prospectively studied a cohort of 26 infants < 32 weeks who had invasive procedures within 3 hours of birth performed in the NICU at NMH between November 2018 and June 2019. Almost three-quarters [19/26 (73%)] had an abnormal temperature at the beginning of the procedure; and 17/26 (65%) had an abnormal temperature at the end of the procedure. Only 3 (11%) infants maintained a normal temperature throughout the procedure. Perhaps more concerning is the severity of the hypothermia observed; 13 (50%) infants had a temperature < 36.0oC before and 11 (42%) after the procedure. The median duration of procedure was 53 (37, 73) minutes.(3)

The investigators think that in extremely preterm infants, placing a peripheral intravenous cannula on admission to the NICU, instead of umbilical catheters (UVC and/or UAC), will increase the proportion of infants with a rectal temperature in the normal range at 2 hours of life.

Enrollment: 116 estimated patients

Sex: All

Ages: 1 to 60 minutes old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• inborn infants admitted to the NICU with;
• gestational age < 29 weeks (up to 28+6 weeks) OR
• birth weight < 1250g.

Exclusion criteria

• end of life (palliative) care
• large abdominal wall defects
• imperforate anus.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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116 participants in 2 patient groups

Intervention

Experimental group

Description:

Insertion of peripheral venous catheter on admission to the NICU

Treatment:

Procedure: Vascular access on admission

Control

No Intervention group

Description:

Insertion of and umbilical venous catheter on admission